Quality Assurance Sample Management

Keywords Studios•Indianapolis, IN

3d•Onsite

About The Position

The Quality Assurance – Sample Management & Labels role provides quality oversight for the management, labeling, and lifecycle activities of clinical trial materials. This position ensures compliance with applicable Good Manufacturing Practices (GMPs), Good Distribution Practices (GDPs), internal standards, and procedures related to sample management and labeling processes. The role supports both documentation review and hands-on warehouse operations, ensuring accuracy, traceability, and regulatory compliance throughout all activities.

Requirements

Basic computer proficiency, including Microsoft Office and experience with quality and enterprise systems such as TrackWise, QDocs, SAP, and web-based applications.
Previous experience working in a warehouse or controlled storage environment.
Willingness and ability to work in a chilled environment (approximately 5°C).
Physical ability to perform job requirements, including standing, bending, and lifting up to 50 lbs.
Availability to work off-hours and weekends as business needs dictate.
Strong attention to detail and documentation accuracy.
Knowledge of GMP/GDP principles and quality systems.
Effective communication and coordination across cross-functional teams.
Ability to balance administrative responsibilities with hands-on operational tasks.
Proactive mindset with a focus on continuous improvement and compliance.

Responsibilities

Perform Quality Assurance verification of documentation related to the receipt, inspection, storage, retention, and disposition of clinical trial samples, including retention, reference, and RIB samples.
Coordinate sample receipt and inspection activities with cross-functional teams, including API, Drug Product (DP), and vTeams.
Verify sample-related data accuracy and ensure proper documentation and traceability within SAP and other quality systems.
Support annual RIB sample inspections and ensure findings are documented and addressed appropriately.
Manage and oversee the processing of samples for destruction in accordance with approved procedures and regulatory requirements.
Review and approve clinical trial labels to ensure compliance with regulatory, protocol, and internal quality standards.
Review procedures, tools, and workflows; provide feedback and recommendations for continuous process improvement.
Initiate, complete, and provide Quality Assurance oversight for Incident/Issue Investigations (ICI), change controls, and deviations.
Support audits, inspections, and internal assessments as needed.
Perform other duties as assigned to support Quality Assurance and business objectives.